[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Venkatesh Sampath\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100561367","phase-1-inhaled-ciclesonide-study-in-preterm-infants-100561367",false,"NCT06589245","Inhaled Ciclesonide Study in Preterm Infants","The Safety and Toxicity of Inhaled Ciclesonide (i.e., Alvesco) in Preterm Infants at Risk for Developing Bronchopulmonary Dysplasia","Inclusion Criteria:\n\n* Viable Infants born between 23 0\u002F7 - 29 6\u002F7 gestation\n* Requiring invasive (through an endotracheal tube) mechanical ventilation\n* Between day of life 8 to 35.\n* Infants have not received dexamethasone for 120 hours\n* If receiving hydrocortisone, then receiving ≤ 1mg\u002Fkg\u002Fday\n\nExclusion Criteria:\n\n* Infants with major congenital lung or other organ anomalies, life-threatening illness, active sepsis or NEC, and grade IV hemorrhage will be excluded.\n* Infants receiving DEX therapy will be excluded.\n* We will exclude infants who have had ≥ 1 glucose level \\> 150mg in the 24 hours prior to study entry or those on insulin therapy to treat hyperglycemia. We will exclude infants who have hypertension (\\>95% centile for gestational age) in the 48 hours prior to study entry.\n* For small for gestational age, we will exclude infants with a birthweight \\\u003C 5% centile for gestational age.\n* Infants with history of recent pulmonary hemorrhage (within 72 hours of study entry) will also be excluded.\n* Infants receiving or have received any dexamethasone in the prior 120 hours.\n* Infants receiving \\>1mg\u002Fkg\u002Fday of hydrocortisone.\n* Infants receiving any other inhaled or systemic steroid.","ALL","8 Days","35 Days",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","Our overall objective is to conduct a safety study with inhaled ciclesonide to evaluate known glucocorticoids (sGC)-related acute and intermediate toxic effects while measuring for the first time in neonates its systemic absorption and potential bioactivity (i.e. activation of primary target, the GR, in blood cells).",[27],"Bronchopulmonary Dysplasia","RECRUITING","2026-03-26",{"date":31,"type":32},"2026-03-27","ACTUAL",{"date":34,"type":32},"2025-09-16",{"date":36,"type":21},"2026-08-31",{"name":38,"class":39},"Venkatesh Sampath","OTHER",""]